Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling
This study has been completed.
Information provided by:
Seoul National University Hospital
First received: November 20, 2009
Last updated: November 17, 2013
Last verified: November 2013
In this study the investigators plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.
Hematopoietic Stem Cell Transplantation
||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Determination of Optimal Busulfan Dose Using Pharmacokinetic Modeling in Hematopoietic Stem Cell Transplantation
Primary Outcome Measures:
- To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation. [ Time Frame: For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate survival, toxicities, engraftment rate of patients received optimal dose of busulfan. [ Time Frame: 1, 3, 6 and 12 months after transplantation ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2012 (Final data collection date for primary outcome measure)
Experimental: Busulfan, Pharmacokinetic
To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation.
First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study we plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.
|Ages Eligible for Study:
||up to 19 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Hematopoietic stem cell transplantation with busulfan based conditioning
- Age: no limits.
- Performance status: ECOG 0-2.
- Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction > 30% and ejection fraction > 45%. 2. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal. 3. Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.
- Patients must lack any active viral infections or active fungal infection.
- Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
- Patients (or one of parents if patients age < 19) should sign informed consent.
- Pregnant or nursing women.
- Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
- Psychiatric disorder that would preclude compliance.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01018446
|Seoul National University Hospital
|Seoul, Daehangno, Jongno-gu, Korea, Republic of, 101 |
Seoul National University Hospital
||Hyoung Jin Kang, M.D., Ph.D
||Seoul National University Hospital
No publications provided
||Korea National Enterprise for Clinical Trials
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 20, 2009
||November 17, 2013
||Korea: Food and Drug Administration
Keywords provided by Seoul National University Hospital:
Hematopoietic stem cell transplantation with busulfan based conditioning
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs